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临床试验/NCT07212400
NCT07212400招募中不适用

Collection of Stool From Healthy Donors for the ex Vivo Study of Shifts of Microbiome Induced by Dairy Phages and Antibiotics: a Model of Bacteria/Host Interaction

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2025年10月16日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
4
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

The gut microbiota plays a crucial role in health through its involvement in pathogen defense, immune regulation, and nutrient digestion. Microbiota diversity is essential to maintain these functions, and disturbances caused by antibiotic intake or extreme diets can lead to an imbalance (dysbiosis), which is often described as being implicated in numerous diseases as well as in the proliferation of antibiotic-resistant pathogens.

The microbiota is defined as the community of microorganisms inhabiting the intestine, including bacteria, viruses, and bacteriophages (phages). These phages, through their ability to destroy the bacteria they infect, play an important role in regulating bacterial populations and could therefore be essential for restoring balance and diversity in the gut.

Probiotics, foods that support the microbiota such as dairy products, are of particular interest because the specific interactions between phages and bacteria within these food microbiomes could stimulate microbiota restoration.

This study aims to evaluate the effectiveness of phage-based functional foods in restoring intestinal homeostasis and, by extension, improving human health. It will serve as a model to examine how phages present in foods, particularly dairy products, influence gut microbial diversity and to determine whether these phages promote recovery after antibiotic-induced disturbances.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years and ≤ 60 years
  • Varied and balanced omnivorous diet

排除标准

  • Vegetarian, vegan, or restrictive diet
  • Use of medications (antibiotics, anti-inflammatory drugs, immunosuppressants, and/or probiotics, prebiotics, or synbiotics), either as drugs or dietary supplements, within the 3 months prior to sample collection
  • Pregnant and/or breastfeeding women
  • Presence of an acute or chronic disease (gastrointestinal, metabolic, immune, or inflammatory), diagnosed or suspected
  • Colonoscopy within the past 3 months
  • Known food allergy or intolerance (e.g., gluten, lactose, FODMAPs) that may alter the usual diet and/or microbiota composition
  • Individuals under legal protection (guardianship, trusteeship, etc.)

结局指标

主要结局

Primary Outcome

时间窗: Up to 3 years

To assess the ability of dairy phages to modulate the intestinal microbiota in vitro using a fermenter system, in the presence and absence of antibiotics.

Secondary Outcome

时间窗: Up to 3 years

To monitor the temporal dynamics of the intestinal microbiota following the addition of dairy phages and antibiotics.

次要结局

未报告次要终点

研究者

研究点 (1)

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